Neurological Outcome After Erythropoietin Treatment for Neonatal Encephalopathy

This study has been completed.
Sponsor:
Collaborators:
Zhengzhou Children's Hospital, China
Medical University Innsbruck
Göteborg University
Information provided by:
Zhengzhou University
ClinicalTrials.gov Identifier:
NCT00808704
First received: December 15, 2008
Last updated: NA
Last verified: December 2008
History: No changes posted
  Purpose

Perinatal asphyxia-induced brain injury is one of the most common causes of morbidity and mortality in term and preterm neonates, accounting for 23% of neonatal deaths globally. Although many neuroprotective strategies appeared promising in animal models, most of them have failed clinically. Erythropoietin (EPO) is an endogenous cytokine originally identified for its role in erythropoiesis. Clinical trial has demonstrated the safety and efficacy of recombinant human erythropoietin (r-hu-EPO) in the prevention or treatment of anemia of prematurity. To date, there are no reports evaluating possible effects of EPO on neonatal HIE.


Condition Intervention Phase
Hypoxic-Ischemic Encephalopathy
Drug: recombinant human erythropoietin
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Erythropoietin on Neonatal Hypoxic Ischemic Encephalopathy

Resource links provided by NLM:


Further study details as provided by Zhengzhou University:

Primary Outcome Measures:
  • Mortality and disability rate. Mortality and disability rate at 18months of age. [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]

Enrollment: 167
Study Start Date: August 2003
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: recombinant human erythropoietin
    r-hu-EPO were administered either 300 U/kg or 500 U/kg, subcutaneously the first time and then intravenously every other day for 2 weeks.
    Other Name: EPO
Detailed Description:

Hypoxic-ischemic encephalopathy of the newborn infant remains a significant socio-economic health problem worldwide. Moderate to severe HIE of newborn infants is associated with a high rate of death or long-term disabilities. Historically, treatment has been purely supportive including stabilizing cardio-respiratory functions and treating convulsions.Recent multi-center trials assessing the effects of hypothermia demonstrated improved outcome in term neonates with moderate hypoxic-ischemic encephalopathy (HIE). However, hypothermia was not effective beyond 6 hrs after brain injury.

Systemically administered EPO was neuroprotective in neonatal brain injury models. Clinical study on adult stroke showed improved outcome. However, treating HIE with EPO raises a series of questions such as: i) Can the patient population of this study readily be compared with those in the hypothermia trials? ii) What are the pharmacokinetics of EPO, including issues of dosage and timing, and does administered EPO cross the blood-brain-barrier? iii) How does the effectiveness, side effects and potentials of EPO therapy compare with induced hypothermia?

  Eligibility

Ages Eligible for Study:   up to 48 Hours
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Apgar score of 5 or less at 5 min after birth or continued need for resuscitation, including endotracheal or mask ventilation at 10 min after birth.
  • The severity of encephalopathy, moderate or severe, was assessed by certified examiners according to the criteria of Sarnat and Sarnat(13), consisting of altered state of consciousness: lethargy, stupor or coma, and at least one or more of hypotonia, abnormal reflexes including oculomotor or pupillary abnormalities, absent or weak sucking or clinical seizures.

Exclusion Criteria:

  • Major congenital abnormalities, head trauma or skull fracture causing major intracranial hemorrhage, mild HIE, financial problems of the parents, lack of permanent address or postnatal age > 48 hrs
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00808704

Locations
China, Henan
NICU, the Third Affiliated Hospital, Zhengzhou University
Zhengzhou, Henan, China, 450052
Sponsors and Collaborators
Zhengzhou University
Zhengzhou Children's Hospital, China
Medical University Innsbruck
Göteborg University
Investigators
Study Director: Changlian Zhu, MD, PhD Zhengzhou University
  More Information

No publications provided

Responsible Party: Professor Xiaoyang Wang, Zhengzhou University
ClinicalTrials.gov Identifier: NCT00808704     History of Changes
Other Study ID Numbers: HN-200312
Study First Received: December 15, 2008
Last Updated: December 15, 2008
Health Authority: China: Ministry of Health

Keywords provided by Zhengzhou University:
asphyxia
erythropoietin
neonates

Additional relevant MeSH terms:
Brain Diseases
Brain Ischemia
Hypoxia-Ischemia, Brain
Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Hypoxia, Brain
Nervous System Diseases
Pathologic Processes
Vascular Diseases
Epoetin alfa
Hematinics
Hematologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014